# K162832: 731 Series Ventilators

- Pathway: 510(k) (Traditional)
- Applicant: ZOLL Medical Corporation
- Decided: Aug 2, 2017 after 295 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K902859 (1991). 129 ancestors in all.
1 later device descends from it; 1 cites it directly.
14 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111473: Uni-Vent (R) Model 731 Series Portable Critical Care Ventilator, Impact Instrumentation, Inc. (2012) Summary page 4.
- K070594: Palmtop Ventilator, Models PTV-8, PTV-10, Pulmonetic Systems, Inc. (2007) Summary page 4.
- K120670: Hamilton-T1, Hamilton Medical AG (2012) Summary page 4.
- K103211: Avea Ventilator, Care Fusion (2011) Summary page 4.

## Most influential descendants
- K233486: 731 Series Ventilator (2024), 0 descendants of its own

## Recalls of this device
- Apr 30, 2024 · Class I · Z-2130-2024: Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manuals. Update to the instructions ensures sa

## Indications for use
Each model of the ZOLL 731 Series of Ventilators is indicated for use in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an "MRI conditional" label, ZOLL Ventilators are suitable for use in an MRI environment with appropriate precautions. ZOLL Ventilators are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers The ZOLL Ventilator pulse oximeter with Masimo SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate. The pulse SpO2 oximeter and accessories are indicated for use on adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.

Source page: https://510kreport.com/device/K162832
Methodology: https://510kreport.com/methodology